RX Series Copper (Cu) Assay Ref. Number CU2340

FDA device recall Z-0992-2024 · posted 2024-02-06 · Open, Classified

Recall details

Recalling firm

Randox Laboratories Ltd.

Reason for recall

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

Action taken

RANDOX Distributors issued Medical Device Correction Letter (REC704) on December 12, 2023 to US consignees. Letter states reason for recall, health risk and action to take: Review your instrument testing order in line with the Carryover Avoidance Technical Bulletin (RXTB-0148) " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0148) and ensure all operators are aware of the recommendations. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.

Root cause

Component design/selection

Status

Open, Classified

Product code

JKZ

Quantity affected

3,053 kits (2 US, 3,051 OUS)

Distribution

US Nationwide distribution in the states of SC and OK.

Date initiated

2023-11-29

Date posted

2024-02-06

Location

Crumlin, North, Ireland